BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3780033 · Received January 6, 2014

    Report

    Report Number
    1314492-2014-00867
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 9, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF. NO.: (B)(4). BAXTER DID NOT RECEIVE AND WAS NOT ABLE TO EVALUATE ANY OF THE DEVICES. WHEN A DEVICE IS RECEIVED AND THE EVAL IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE CUSTOMER WAS GIVEN INSTRUCTIONS ON WHY SYSTEM ERROR 322'S OCCUR AND HOW TO PREVENT THEM. IF THE REQUIRES MORE INFO A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PUMPS WERE ALARMING FOR SYSTEM ERROR 322. SOME OF THE ERRORS OCCURRED DURING PT CARE, INTERRUPTING IT. AN EXPLANATION WAS REQUESTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8228 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1